Bayer seeks approval of finerenone in heart failure in EU
Berlin: Bayer has announced the submission of a marketing authorization application to the European Medicines Agency (EMA), seeking approval in the EU for the use of finerenone in adult patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced LVEF (HFmrEF) or preserved LVEF (HFpEF).
Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) and a drug targeting the mineralocorticoid receptor (MR) pathway that has demonstrated cardiovascular benefits in patients with HF with a left ventricular ejection fraction (LVEF) of ≥40% in the Phase III study FINEARTS-HF. Finerenone is already marketed as Kerendia or, in some countries, as Firialta, and approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 90 countries worldwide, including in China, Europe, Japan, and the U.S.
“Treating heart failure with an LVEF of 40% or greater poses unique challenges, leaving patients with few effective therapeutic options,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. "If approved, finerenone has the potential to become a new pillar in addressing this common form of heart failure, offering hope for improved outcomes in a patient population that has long been underserved."
Heart failure is a rapidly growing public health issue affecting over 60 million people worldwide and at least 15 million people in Europe alone. Approximately half of these patients suffer from HF with a LVEF of ≥40%, which is associated with multiple comorbidities, making the condition complex to manage. Time trends suggest this growing population will soon account for the majority of patients hospitalized with HF. According to a study, the estimated costs related to heart failure in the EU in one year is about 29 billion Euros. The bulk of the costs is driven by repeat hospitalizations.
By targeting MR and renin-angiotensin-aldosterone system (RAAS) overactivation, finerenone addresses key aspects of HF with an LVEF ≥40%, including hemodynamic factors and inflammatory and fibrotic processes. Results from the Phase III study FINEARTS-HF demonstrate that compared to placebo, finerenone showed a statistically significant improvement in cardiovascular outcomes in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≥40%.
Finerenone has also been submitted for marketing authorization in this common form of heart failure in the U.S. and in China, and these applications are currently under review. Further regulatory applications to health authorities in other countries worldwide will follow. Submissions are based on positive data from the FINEARTS-HF study, which is part of MOONRAKER, one of the largest Phase III clinical trial programs to date in HF with more than 15,000 patients in total, aiming to establish a comprehensive understanding of finerenone in HF across a broad spectrum of patients and clinical settings.
